21 CFR 338.10
§ 338.10 Nighttime sleep-aid active ingredients.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 338.10, § 338.10 Nighttime sleep-aid active ingredients, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86557
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Full text
The active ingredient of the product consists of any of the following when used within the dosage limits established for each ingredient in § 338.50(d):
(a) Diphenhydramine hydrochloride.
(b) Diphenhydramine citrate.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.